Abstract: A multicenter, open-label trial to assess the safety and tolerability of a single intravenous loading dose of lacosamide followed by oral maintenance as adjunctive therapy in subjects with partial-onset seizures: an interim report
In this study, patients currently taking one to two AEDs were grouped into three, 25-patient cohorts and given three progressively increasing doses of intravenous lacosamide (200 mg, 300 mg and 400 mg) administered via 15-minute infusions, followed by the same dose of the oral form given twice-daily for 6.5 days.
The first three cohorts (200 mg, 300 mg and 400 mg loading dose) have completed the trial. All subjects in the first cohort (200 mg loading dose) completed the trial. One subject (4 percent) from the second cohort (300 mg loading dose) and four subjects (16 percent) from the third cohort (400 mg loading dose) withdrew due to adverse events.
Based on results of these cohorts, enrollment of the fourth repeat cohort will proceed with the highest well-tolerated loading dose. Additional data on safety and tolerability will be presented during the poster session at AES.
Poster Session 2, Sunday, December 6, 4:00 pm - 5:00 pm, Hall D, Level 2 (Abstract 2.222)
Nathan B. Fountain 1, Gregory Krauss 2, Jouko Isojarvi 3, Deanne Dilley 3, Pamela Doty 3
1 University of Virginia, Charlottesville, Virginia; 2 John Hopkins University, Baltimore, Maryland; 3 Schwarz Biosciences (a member of the UCB Group), Raleigh, North Carolina
Important safety information about Vimpat® in the U.S.
Vimpat® (lacosamide) is a medicine that is use
Copyright©2009 PR Newswire.
All rights reserved